News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Supreme Court Strikes down Myriad Gene Patents in Unanimous Vote; Decision Is Expected to Benefit Clinical Pathology Laboratories

Pathologists and clinical laboratory managers can expect to see an expansion of genetic testing in the wake of the Supreme Court’s decision in the Myriad case

Pathologists and clinical laboratory professionals got a major victory on June 13. That’s when the United States Supreme Court (SCOTUS) ruled 9-0 to end the 30-year-old practice of awarding patents on human genes. The unanimous decision invalidates certain hotly contested patents held by Myriad Genetics, Inc., (NASDAQ: MYGN) on the BRCA1 and BRCA2 genes.

Moreover, this Supreme Court decision also opens the doors to other medical laboratories  to develop their own diagnostics around the BRCA genes and compete for breast-cancer testing market share. (more…)

ENCODE Project Reveals 4 Million Critical Gene Switches in “Junk” DNA of Humans

Pathologists and clinical laboratory managers may see an explosion of new diagnostic tests in the wake of ENCODE’s discoveries

You know it’s big news when multiple scientific journals publish numerous papers on the same day, covering the same genetic research topic. That is why pathologists and clinical laboratory professionals will want to learn more about “ENCODE,” the global research initiative that is the source of almost 40 published papers during recent weeks.

Of equal importance, this is basic science that is unlocking knowledge of human DNA that is expected to drive an entire new field of medical diagnostics. In turn, the host of new medical laboratory tests based on ENCODE’s new scientific findings will create additional opportunities for the nation’s clinical laboratories to deliver more value to physicians and patients. (more…)

FDA Issues Proposed Rule on Medical Device UDI System That Will Also Apply to Clinical Pathology Analyzers and Lab Products

Many products that medical laboratories use will be covered under the new UDI system

You’re reading it here first! UPCs—universal product codes—are coming soon to the medical laboratory analyzers and other products that your clinical laboratory purchases. Under a proposed rule published by the Food and Drug Administration (FDA), medical devices will soon have UDIs—universal device identifiers.

You know about UPCs. Those are the ubiquitous “universal product codes” that are found on literally every retail product. UPCs make scanning at the cash register possible. Now a similar system is coming to medical devices, including the lab analyzers, reagents, and other products used by medical laboratories and pathology. (more…)

Super-Fast Microscope Captures Circulating Tumor Cells with High Sensitivity and Resolution in Real Time

Pathology groups and clinical labs could use the world’s fastest camera to diagnose cancer at earlier stages

There’s a new optical microscope that can detect rogue cancer cells. It was developed by engineers at the University of California Los Angeles (UCLA). The achievement could create new diagnostic capabilities for pathology and clinical laboratory medicine.

New Instrument Detects Circulating Tumor Cells

The target for this new high-speed microscope are Circulating cancer tumor cells (CTC). CTCs are the precursors to metastasis and metastatic cancer accounts for about 90% of cancer mortalities. However, CTCs are difficult to find and identify. Among a billion healthy cells, only a minute number of CTCs exist. (more…)

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